Currently under review at the FDA, Abbott’s miniaturized, leadless pacemaker has aced a clinical study by showing it could speed up the beat of a patient’s heart once its rhythm falls out of sync.
The company’s Aveir system aims to provide ventricular pacing on-demand—triggering an electrical pulse only when needed to get a slowing heart back on track, instead of a constant cadence.
The minimally invasive device is also designed to be easily retrievable by a surgeon when the battery needs to be replaced or a patient’s course of therapy needs to be updated, without requiring an incision in the chest.
Implanted directly into the heart's right ventricle using a catheter snaked through the patient’s blood vessels, the device skips the need for wires and electrodes to be threaded into the cardiac muscle.
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In the nonrandomized, global pivotal study—dubbed Leadless II—participants were tracked for six weeks after implantation to catch any side effects or complications. During this time the device’s pacing efficacy met the trial’s thresholds, and 96% of patients saw no serious adverse events, according to Abbott. The study will also log patients’ survival rate over two years.
“The Aveir can only support the ventricular rhythm, so in people who normally have their own heart rate all the time and they just need some support infrequently, it's good to use,” said study investigator Judith Mackall, who helped lead the trial at University Hospitals’ Harrington Heart & Vascular Institute.
“What's nice about it is that it uses much less energy to pace the heart than typical wires. The battery in these devices is expected to last a relatively long time, usually 12 to 13 years,” Mackall said in a statement earlier this year while the study was ongoing.
While the Aveir is only designed to sync up the heart’s main ventricles—or the stronger second half of the pulse’s two-step beat and the muscles that push blood out to the rest of the body—a future wireless device aimed at the atria, under development at Abbott, would help provide a more complete pacemaker solution.
“If you had a leadless atrial pacemaker that talks to the leadless ventricular pacemaker, you would then be able to pace and sense in the top chambers and the bottom chambers. You'd be able to keep the heartbeats in sync which is ideal for people who need pacing support and are in normal rhythm,” said Mackall, who also serves as director of the device clinic at UH Cleveland Medical Center. “With this Leadless II trial, we're in the beginning phase where we're just putting in the ventricular pacemaker, but we see that this will lead to a dual-chamber trial.”
In January 2020, Medtronic snagged an FDA green light for its Micra AV ventricular leadless pacemaker. Described as one of the world’s smallest, the device is less than a tenth the size of traditional pacemakers.
While placed in the wall of the right ventricle using small tines, the implant aims to tackle bradyarrhythmia as well as atrioventricular block, where electrical signals from the heart’s upper atria have trouble reaching its lower, pumping ventricles. The device also includes internal sensing algorithms and accelerometers that detect the movement of the muscle with each heartbeat and adjust its electrical pacing to synchronize.
Earlier this year, Medtronic presented new data showing the Micra led to fewer complications and fewer patients returning to the operating room compared to wired cardiac implants over two years.